Prepare to Care, A Supported Self-Management Intervention for Head and Neck Cancer CaregiversHead and Neck Cancer

Not Applicable

Completed

• Conditions: Stage II Laryngeal Squamous Cell Carcinoma; Stage IV Lip and Oral Cavity Squamous Cell Carcinoma; Paranasal Sinus Squamous Cell Carcinoma; Stage I Laryngeal Squamous Cell Carcinoma; Stage I Lip and Oral Cavity Squamous Cell Carcinoma; Stage III Oropharyngeal Squamous Cell Carcinoma; Stage IVA Lip and Oral Cavity Squamous Cell Carcinoma; Stage IVB Hypopharyngeal Squamous Cell Carcinoma; Recurrent Head and Neck Squamous Cell Carcinoma; Recurrent Laryngeal Squamous Cell Carcinoma
• Interventions: Other: Watch video; Other: Communication Intervention; Other: Module completion of the Prepare to Care kit; Other: Quality-of-Life Assessment; Other: Survey Administration; Other: Salivary cortisol collection

• Registration Number: NCT03032250
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

This pilot clinical trial studies how well Prepare to Care kit works in improving caregiver support in patients with stage I-IV head and neck cancer that is new or has come back. Prepare to Care kit may increase knowledge about head and neck cancer and enhance stress-management skills.

Detailed Description

PRIMARY OBJECTIVES:

I. To assess feasibility (accrual, participation, and retention) and acceptability of a supported self-management intervention for psycho-education and stress management skills building designed for informal caregivers (intervention group n=20; waitlist control group, n=20) of head and neck cancer (HNC) patients undergoing radiotherapy (RT).

II. To obtain preliminary data on caregiver intermediate (self-efficacy for \[a\] coping with cancer and \[b\] abbreviated progressive muscle relaxation) and outcome variables (burden, psychological distress, quality of life) in intervention caregivers and waitlist control caregivers at the start of radiation (T1), end of radiation (T2), and 6-weeks post-radiation (T3).

III. To compare intermediate (self-efficacy for (a) coping with cancer and (b) abbreviated progressive muscle relaxation) and outcome variables (burden, psychological distress, quality of life) between intervention caregivers and waitlist control caregivers at T1, T2, and T3.

IV. To obtain preliminary data on caregiver cortisol response (cortisol slope, cortisol awakening

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Caregivers watch introduction video on a digital video disc (DVD) over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly.

GROUP II: Caregivers receive educational intervention as in Group I but do not attend interventionist sessions.

Study Timeline

• Study First Submitted: 2017-01-17
• Study First Submitted QC: 2017-01-23
• Study First Posted: 2017-01-26
• Study Start: 2017-05-15
• Primary Completion: 2020-04-10
• Study Completion: 2020-04-10
• Results First Submitted: 2021-04-23
• Results First Submitted QC: 2021-06-09
• Results First Posted: 2021-07-01
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-14
• Last Update Posted: 2023-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

CAREGIVERS:

• Providing the majority of the informal (unpaid) care during radiation therapy for a patient meeting inclusion criteria and participating in study

CARE-RECIPIENTS:

• Has a new or recurrent American Joint Committee on Cancer (AJCC) stage I-IV squamous cell carcinoma of the upper aerodigestive tract (including lip/oral cavity, nasopharynx, salivary gland, oropharynx, hypopharynx, paranasal sinus, and larynx cancers)
• Has planned external beam radiotherapy (+/- chemotherapy) for 6-7 weeks
• Has an informal (unpaid) caregiver during radiation therapy who is participating in study

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Exclusion Criteria

• CAREGIVERS: Has a current cancer diagnosis
• CAREGIVERS: Cannot read/communicate in English
• CAREGIVERS: Have an endocrine disorder (e.g., diabetes and thyroid disorders), or is currently taking a steroid based medication will not be eligible to participate in the saliva portion of the study
• CARE-RECIPIENTS: Cannot read/communicate in English

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I Supportive Care (Prepare to Care kit)	Survey Administration	Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly.
Group I Supportive Care (Prepare to Care kit)	Salivary cortisol collection	Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly.
Group II Control Group	Module completion of the Prepare to Care kit	Caregivers received standard of care throughout course of intervention, with option to receive study intervention at end of study
Group II Control Group	Watch video	Caregivers received standard of care throughout course of intervention, with option to receive study intervention at end of study
Group II Control Group	Salivary cortisol collection	Caregivers received standard of care throughout course of intervention, with option to receive study intervention at end of study
Group I Supportive Care (Prepare to Care kit)	Quality-of-Life Assessment	Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly.
Group I Supportive Care (Prepare to Care kit)	Communication Intervention	Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly.
Group I Supportive Care (Prepare to Care kit)	Watch video	Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly.
Group I Supportive Care (Prepare to Care kit)	Module completion of the Prepare to Care kit	Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly.
Group II Control Group	Quality-of-Life Assessment	Caregivers received standard of care throughout course of intervention, with option to receive study intervention at end of study
Group II Control Group	Survey Administration	Caregivers received standard of care throughout course of intervention, with option to receive study intervention at end of study

Primary Outcome Measures

Name	Time	Method
Accrual Assessed by Number of Caregivers Who Agreed to Participate Divided by the Number of Months of Recruitment	Up to 1 year	38 patient/caregiver dyads agreed to participate, 22 months of recruitment, for accrual rate of 1.7 (caregiver) participants per month
Change in Caregiver Burden Assessed by Caregiver Reaction Assessment (CRA)	Baseline and following radiotherapy, assessed up to 1 year	21-item instrument assessing positive and negative aspects of caregiving (esteem, lack of family support, finances, schedule, and health). The CRA has been tested in cancer caregivers; demonstrated validity and reliability. Minimum and maximum scoring scale: BASELINE: Scores for esteem 15-31; lack of family support 5-15, impact of finances 3-12, impact of schedule 12-23, impact of health 11-16). AFTER RADIOTHERAPY: Scores for esteem 20-31; lack of family support 9-17, impact of finances 7-11, impact of schedule 14-22, impact of health 12-17). The higher the score the more the item being assessed impacted the participant.
Number of Participants Noting Quite a Bit/Very Much Helpful to Survey Questions	Six weeks post radiation therapy	10-item quantitative survey will be developed for study to assess how much caregivers liked different aspects of the intervention. Acceptability will be summarized quantitatively and qualitatively. These acceptability questions were asked only of caregivers in the intervention group - Group 1 Supportive Care (Prepare to Care Kit). All data is based on participants answering the acceptability questions as "Quite a Bit/Very Much Helpful" for the intervention materials. Not all participants answered this part of the outcome measure.
Change in Psychological Distress - Center for Epidemiological Studies Depression (CESD)	Before and after radiotherapy, assessed up to 1 year	The score is the sum of the 20 questions. Possible scoring range is 0-60. A score of 16 points or more is considered depressed.
Change in Quality of Life Assessed by Caregiver Quality of Life Index-Cancer (CqoL-Canc)	Before and after radiotherapy, assessed up to 1 year	35-item instrument assessing dimensions of caregiver quality of life (burden, disruptiveness, positive adaptation, financial concerns). The Cqol-Canc has demonstrated validity and reliability. Minimum and maximum score at baseline is a range of 9-78 and after radiotherapy a range of 2-73. The higher the score the greater the level of change in the quality of life for participants.
Frequency of Intervention Modules Utilized Assessed by Caregiver Logs	Up to 1 year	Data on intervention resources used and time spent using them based on caregivers in intervention group
Number of Participants in Agreement to Perform Interventions	Up to 1 year	Participation assessed by number of eligible participants who agreed to participate and complete study interventions.
Retention Assessed by Number of Participants Who Completed the End of Radiotherapy Visit Divided by the Number Who Agreed to Participate	Up to 1 year
Self-efficacy in Abbreviated Progressive Muscle Relaxation (APMR)	At baseline and up to the end of radiotherapy, assessed up to 1 year	A 3-item instrument developed for study to evaluate self-efficacy in APMR. Minimum to maximum scores range from 3-27. Higher scores demonstrate higher self efficacy in participants.
Self-efficacy in Coping With Cancer Caregiver Inventory	At baseline and up to the end of radiotherapy, assessed up to 1 year	21-item instrument assessing caregivers' perceived self-efficacy for coping with cancer (managing medical information, caring for care recipient, caring for oneself, managing difficult interactions/emotions); demonstrated validity and reliability. Minimum and maximum scores range from 10-63. Higher scores indicate higher self-efficacy in coping with cancer from the participants.

Trial Locations

Locations (1)

Comprehensive Cancer Center of Wake Forest University; 🇺🇸 Winston-Salem, North Carolina, United States